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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

medication start dose is 10mg. After 6 weeks of treatment will be force-titrated to 20mg.

The primary objective is to evaluate the efficacy of rosuvastatin therapy on plasma lipid profile (Low Density Lipoprotein (LDL), High-Density Lipoprotein (HDL), total cholesterol, triglyceride) in patients with metabolic syndrome.

Effect of Crestor (Rosuvastatin) on lipid levels in patients with metabolic syndrome

Research site

Research Site

Open-labelled, single arm, Phase IV clinical study to evaluate the impact of rosuvastatin on lipid levels in patients with metabolic syndrome (EFFORT)

HDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)

HDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LDL-cholesterol levels before (mean of visit 1 - screening and Visit 2 - enrollment)

LDL- cholesterol levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Total cholesterol after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Triglyceride levels before (mean of visit 1 - screening and Visit 2 - enrollment)

Triglycerides after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin treatment.  Target level: LDL-cholesterol: <100 mg/dL; HDL-cholesterol: For males >40 mg/dL, for females >50 mg/dL; non-HDL-cholesterol: <130 mg/dL

Number of patients who reached target level of HDL-cholesterol after 3 months of rosuvastatin treatment

Number of patients who reached target level of non-HDL-cholesterol after 3 months of rosuvastatin treatment

Age Continuous

Gender, Male/Female

Basal HDL-cholesterol level

LOCF (Last Observation Carried Forward) HDL levels of participants

HDL-cholesterol  level after 3 months of rosuvastatin treatment

Basal LDL-cholesterol level

LOCF (Last Observation Carried Forward) LDL levels of participants

LDL-cholesterol  level after 3 months of rosuvastatin treatment

Baseline total cholesterol levels of participants

Basal total cholesterol level

LOCF (Last Observation Carried Forward) total cholesterol levels of participants

Total cholesterol  level after 3 months of rosuvastatin treatment

Baseline triglyceride levels of participants

Basal triglyceride level

LOCF (Last Observation Carried Forward) triglyceride levels of participants

Triglyceride level after 3 months of rosuvastatin treatment

LDL cholesterol levels < 100 mg/dL, calculated over patients with lipid measurement performed at both visits

Number of patients who reached target level of LDL-cholesterol after 3 months of rosuvastatin  treatment

HDL cholesterol target levels for males >40 mg/dL, for females > 50 mg/dL, calculated over patients with lipid measurement performed at both visits

Non-HDL cholesterol target levels <130 mg/dL, calculated over patients with lipid measurement performed at both visits

Basal interleukin 1 (IL-1) level

IL-1 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward) IL-1 levels of participants

Interleukin 1 (IL-1) level after 3 months of rosuvastatin treatment

Basal interleukin 6 (IL-6) level

IL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward) IL-6 levels of participants

Interleukin 6 (IL-6) level after 3 months of rosuvastatin treatment

Basal interleukin 8 (IL-8) level

IL-8 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward) IL-8 levels of participants

Interleukin 8 (IL-8) level after 3 months of rosuvastatin treatment

Basal interleukin 10 (IL-10) level

IL-10 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward) IL-10 levels of participants

Interleukin 10 (IL-10) level after 3 months of rosuvastatin treatment

Baseline Basal Tumor Necrosis Factor (TNF) levels of participants

Basal tumor necrosis factor (TNF) level

TNF levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward) Tumor Necrosis Factor (TNF) levels of participants

Tumor necrosis factor (TNF) level after 3 months of rosuvastatin treatment

hs-CRP  levels before (Visit 2-enrollment)

Baseline High Sensitivity C-reactive protein (Hs-CRP) levels of participants

Basal high sensitivity C-reactive protein (hs-CRP) level

hs-CRP levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward) High Sensitivity C-reactive protein (Hs-CRP) levels of participants

High sensitivity C-reactive protein (hs-CRP) level after 3 months of rosuvastatin treatment

LDL subfractions are light (LDL1 and 2), intermediate (LDL3) and small dense LDL (LDL 4, 5, 6 and 7). Small dense LDL (sdLDL)-cholesterol that expresses greater atherogenicity than large buoyant LDL. Large LDL particles are the least likely to cause plaque formation, because LDL particles have to be approximately 25 nm in diameter or smaller to penetrate the artery walls. High sdLDL and decreased large HDL fraction are more common in patients with coronary heart disease than in controls

Basal LDL-3 level

LDL-3 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward)  LDL-3 levels of participants

LDL-3 level after 3 months of rosuvastatin treatment

LDL-4  levels before (Visit 2-enrollment)

Basal LDL-4 level

LDL-4 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF(Last Observation Carried Forward)  LDL-4 levels of participants

LDL-4 level after 3 months of rosuvastatin treatment

LDL-5  levels before (Visit 2-enrollment)

Basal LDL-5 level

LDL-5 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward)  LDL-5 levels of participants

LDL-5 level after 3 months of rosuvastatin treatment

LDL-6  levels before (Visit 2-enrollment)

Basal LDL-6 level

LDL-6 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward)  LDL-6 levels of participants

LDL-6 level after 3 months of rosuvastatin treatment

LDL-7  levels before (Visit 2-enrollment)

Basal LDL-7 level

LDL-7 levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward)  LDL-7 levels of participants

LDL-7 level after 3 months of rosuvastatin treatment

Large HDL subfraction  levels before (Visit 2-enrollment)

Baseline Large HDL subfraction of participants

Basal large HDL subfraction level

Large HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward)  Large HDL subfraction levels of participants

Large HDL subfraction level after 3 months of rosuvastatin treatment

Intermediate HDL subfraction  levels before (Visit 2-enrollment)

Baseline Intermediate HDL subfraction of participants

Basal intermediate HDL subfraction level

Intermediate HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward)  Intermediate HDL subfraction levels of participants

Intermediate HDL subfraction  level after 3 months of rosuvastatin treatment

Small HDL subfraction  levels before (Visit 2-enrollment)

Baseline Small HDL subfraction of participants

Basal small HDL subfraction level

Small HDL subfraction levels after 3 months of rosuvastatin treatment (last observation carried forward; LOCF)

LOCF (Last Observation Carried Forward)  Small  HDL subfraction levels of participants

Small HDL subfraction level after 3 months of rosuvastatin treatment

Number of patients with any adverse events in 3 months of rosuvastatin treatment

Number of patients with any adverse events in 3 months

Effect of Crestor (Rosuvastatin) on lipid levels in patients with metabolic syndrome - EFFORT

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=322&filename=CSR-D3560L00079.pdf

CSR-D3560L00079.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator